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Echinacea, Propolis and Vitamin C for URI Prevention in Preschoolers

This study has been completed.
Sponsor:
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00231218
First received: September 30, 2005
Last updated: December 13, 2006
Last verified: December 2006

September 30, 2005
December 13, 2006
January 2006
Not Provided
upper respiratory tract infections
Same as current
Complete list of historical versions of study NCT00231218 on ClinicalTrials.gov Archive Site
gastroenteritis
Same as current
Not Provided
Not Provided
 
Echinacea, Propolis and Vitamin C for URI Prevention in Preschoolers
the Effectiveness of Echinacea, Propolis and Vitamin C in the Prevention of Respiratory Tract Infections and Gastroenteritis in Preschool Age Children: a Prospective Study

We hypothesize the herbal preparation will enhance the preschoolers' immune response and when taken prophylactically for 12 weeks will decrease episodes of upper respiratory infections and gastroenteritis in the active versus the control group.

This combination of herbs has been studied only once before in preschoolers. In a study of 430 preschoolers reported in Archives of Pediatric and Adolescent Medicine in March of 2004, a similar preparation with a slightly lower dose of Vitamin C decreased upper respiratory infections by 55% (308 to 138). We are repeating this study to see if our results confirm or contradict those of the previous study.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • Common Cold
  • Gastroenteritis
Drug: dietary supplement--echinacea, propolis, and vitamin c
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
104
March 2006
Not Provided

Inclusion Criteria:

  • Age 3-6

Exclusion Criteria:

  • Cystic fibrosis
  • Immunodeficiency
  • Bronchopulmonary dysplasia
  • Anatomic abnormalities of respiratory tract
  • Intestinal malabsorption
  • Allergy to sunflower seeds
Both
3 Years to 6 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00231218
8348
Not Provided
Not Provided
The Cleveland Clinic
Not Provided
Study Director: michael l macknin, m.d. The Cleveland Clinic
The Cleveland Clinic
December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP